BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3833610 · Received May 27, 2014

    Report

    Report Number
    3005099803-2014-02018
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE FLARE DETACHED AND THE STRAIN RELIEF WAS CURVED. THERE WERE NO KINKS IN THE CATHETER AND THERE WAS EVIDENCE OF THE FLARE PROCESS PERFORMED DURING MANUFACTURING. THE HANDLE CANNULA WAS IN GOOD CONDITION. FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT WAS CONFIRMED. HOWEVER, REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE THE ROOT CAUSE OF THIS COMPLAINT. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF WORKING LENGTH DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS OPENED FOR USE DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE OUTER SHEATH OF THE SNARE WAS FOUND TO BE CRACKED BEFORE THE DEVICE WAS INSERTED INTO THE ENDOSCOPE. THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE INTO THE ENDOSCOPE; HOWEVER, THE OUTER SHEATH BROKE AND EVENTUALLY DETACHED. THE DEVICE AND ITS DETACHED PART WAS REMOVED FROM THE ENDOSCOPE. REPORTEDLY, THERE WAS NO ISSUE IN ADVANCING THE SNARE INTO THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE MEDIUM OVAL SNARE WAS OPENED FOR USE DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE OUTER SHEATH OF THE SNARE WAS FOUND TO BE CRACKED BEFORE THE DEVICE WAS INSERTED INTO THE ENDOSCOPE. THE PHYSICIAN ATTEMPTED TO INSERT THE SNARE INTO THE ENDOSCOPE; HOWEVER, THE OUTER SHEATH BROKE AND EVENTUALLY DETACHED. THE DEVICE AND ITS DETACHED PART WAS REMOVED FROM THE ENDOSCOPE. REPORTEDLY, THERE WAS NO ISSUE IN ADVANCING THE SNARE INTO THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE MEDIUM OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310445 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561831 16280792

    Patients

    Seq Age Sex Outcome Treatment
    1